BEUDAMED
    FDA Adverse Event Injury Summary report: N

    32MM STD LFIT V40 HEAD

    MDR report key: 4626597 · Received March 24, 2015

    Report

    Report Number
    0002249697-2015-00870
    Event Type
    Injury
    Date Received
    March 24, 2015
    Date of Event
    February 26, 2015
    Report Date
    February 26, 2015
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    PMA / PMN Number
    K010757
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REPORTING ALTR INVOLVING AN ACCOLADE STEM (PR 790440) AND METAL HEAD WAS REPORTED. THE EVENT WAS NOT CONFIRMED. METHOD & RESULTS: -DEVICE EVALUATION AND RESULTS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. -MEDICAL RECORDS RECEIVED AND EVALUATION: A MEDICAL REVIEW WAS NOT PERFORMED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. -DEVICE HISTORY REVIEW: REVIEW INDICATED ALL DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. -COMPLAINT HISTORY REVIEW: REVIEW INDICATED THERE HAVE BEEN NO OTHER EVENTS FOR THE REPORTED LOT. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE INSUFFICIENT INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION, INCLUDING OPERATIVE REPORTS, PROGRESS NOTES, PATHOLOGY REPORTS X-RAYS AND RETURN OF THE DEVICE ARE NEEDED TO FULLY INVESTIGATE THE EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON HAD TO REVISE A ACCOLADE HIP THAT WAS PAINFUL TO THE PATIENT. THE PATIENTS COBALT CHROMIUM BLOOD LEVELS WAS 3 TIMES HIGHER THAN NORMAL. AFTER REMOVAL OF THE FEMORAL HEAD, IT WAS NOTICED THAT THE TRUNNION WAS BLACK (SEE ATTACHED PICTURE). THE STEM WAS REMOVED AND REPLACED WITH A EXETER STEM WITH A +8 SS HEAD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SURGEON HAD TO REVISE A ACCOLADE HIP THAT WAS PAINFUL TO THE PATIENT. THE PATIENTS COBALT CHROMIUM BLOOD LEVELS WAS 3 TIMES HIGHER THAN NORMAL. AFTER REMOVAL OF THE FEMORAL HEAD, IT WAS NOTICED THAT THE TRUNION WAS BLACK. THE STEM WAS REMOVED AND REPLACED WITH A EXETER STEM WITH A +8 SS HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196914 32MM STD LFIT V40 HEAD IMPLANT JDI STRYKER ORTHOPAEDICS-MAHWAH 30226601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention